VivaChek Blood Glucose and B-Ketone Monitoring System— 510(k) K192957
Substantially EquivalentVivachek Biotech (Hangzhou) Co., Ltd.
FDA 510(k) clearance K192957 for VivaChek Blood Glucose and B-Ketone Monitoring System, Substantially Equivalent on 2020-06-05. Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
- Product code
- Product code JIN
- Device class
- Class 1
- Regulation
- 21 CFR 862.1435
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.